臨床研究等提出・公開システム

Date of registration	May. 28, 2026
Last modified on	May. 28, 2026
Trial ID	jRCT1070260033

Scientific Title	A Study Examining the Course of Free Hemoglobin and the Degree of Renal Deterioration Following Pulmonary Vein Isolation Using PulseSelect in Patients with Atrial Fibrillation and Concomitant Renal Impairment
Public Title	A Study Examining the Course of Free Hemoglobin and the Degree of Renal Deterioration Following Pulmonary Vein Isolation Using PulseSelect in Patients with Atrial Fibrillation and Concomitant Renal Impairment

Contact for Scientific Queries	Name	Okamatsu Hideharu
	Affiliation	Saiseikai Kumamoto Hospital
	Address	5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Prefecture
	Telephone	+81-96-351-8000
	E-mail	hideharu-okamatsu@saiseikaikumamoto.jp
Contact for Public Queries	Name	Okamatsu Hideharu
	Affiliation	Saiseikai Kumamoto Hospital
	Address	5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Prefecture
	Telephone	+81-96-351-8000
	E-mail	hideharu-okamatsu@saiseikaikumamoto.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 27, 2026
Target sample size		30
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with atrial fibrillation and a serum creatinine level of 1.5 mg/dL or higher who are undergoing their first catheter ablation for atrial fibrillation using the PulseSelect system
	Exclusion Criteria	Patients currently participating in other clinical trials or clinical studies (interventional studies) Left ventricular ejection fraction of 35% or less Left atrial diameter of 55 mm or more Long-standing atrial fibrillation lasting 3 years or longer Serum creatinine < 1.5 mg/dL Patients undergoing maintenance dialysis Post-valvular surgery (including catheter-based procedures) Post-Maze surgery Severe valvular disease Active malignancy Patients who have undergone pulsed-field ablation for indications other than pulmonary vein isolation
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atrial fibrillation
Health Condition(s) Keyword		Atrial fibrillation
Health Condition(s) Code		D001281
Primary Outcome(s)		Degree of increase in free hemoglobin in T2, T3, and T4 Degree of increase in creatinine in T2, T3, and T4 Incidence of kidney disease at Stage 1 or higher according to the KDIGO clinical guidelines
Secondary Outcome(s)		The extent of elevation in total bilirubin and LDH in T2, T3, and T4 The extent of decrease in serum hemoglobin in T2,T3, and T4 The extent of elevation in BUN in T2, T3, and T4 The frequency of patients whose haptoglobin levels fell below the detection limit on the day after surgery

Primary Sponsor	none

Name of Certified Review Board	Saiseikai Kumamoto Hospital Ethics Committee
Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto, Kumamoto
Telephone	+81-96-351-8000
E-Mail	rks@saiseikaikumamoto.jp
Approval Status	Approval
Date of approval	April. 23, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none